zeluvalimab (AMG 404) / Amgen - LARVOL DELTA

CodeBreak101: Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101) (clinicaltrials.gov) - P1 | N=610 | Active, not recruiting | Sponsor: Amgen | Recruiting ➔ Active, not recruiting | N=1200 ➔ 610 | Trial primary completion date: Jun 2026 ➔ Dec 2026

Enrollment change • Enrollment closed • Monotherapy • Trial primary completion date • Brain Cancer • Colorectal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • KRAS

A phase I, open-label, multicentre, first-in-human study to evaluate safety, pharmacokinetics and efficacy of AMG 404, a PD-1 inhibitor, in patients with advanced solid tumours. (PubMed, BMJ Open) - P1 | "AMG 404 monotherapy was tolerable at the tested doses, with encouraging antitumour activity observed across tumour types."

IO biomarker • Journal • P1 data • PK/PD data • Brain Cancer • Gastrointestinal Cancer • Gastrointestinal Disorder • Hematological Disorders • Lung Cancer • Microsatellite Instability • Non Small Cell Lung Cancer • Oncology • Solid Tumor • MSI • PD-L1

CodeBreak101: Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101) (clinicaltrials.gov) - P1 | N=1200 | Recruiting | Sponsor: Amgen | Trial completion date: Mar 2028 ➔ Dec 2027

Monotherapy • Trial completion date • Brain Cancer • Colorectal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • KRAS

CodeBreak101: Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101) (clinicaltrials.gov) - P1 | N=1200 | Recruiting | Sponsor: Amgen | Trial completion date: Jun 2029 ➔ Mar 2028 | Trial primary completion date: Jan 2027 ➔ Apr 2026

Combination therapy • Metastases • Monotherapy • Trial completion date • Trial primary completion date • Brain Cancer • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • KRAS

CodeBreak101: Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101) (clinicaltrials.gov) - P1 | N=1200 | Recruiting | Sponsor: Amgen | Trial completion date: Mar 2028 ➔ Jun 2029 | Trial primary completion date: Sep 2025 ➔ Jan 2027

Combination therapy • Metastases • Monotherapy • Trial completion date • Trial primary completion date • Brain Cancer • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • KRAS

Study of AMG 596 in Patients With EGFRvIII Positive Glioblastoma (clinicaltrials.gov) - P1 | N=30 | Terminated | Sponsor: Amgen | Completed ➔ Terminated; Amgen business decision

Combination therapy • Monotherapy • Trial termination • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor

AMG 757 and AMG 404 in Subjects With Small Cell Lung Cancer (SCLC) (clinicaltrials.gov) - P1 | N=23 | Completed | Sponsor: Amgen | Active, not recruiting ➔ Completed | Trial completion date: Jan 2025 ➔ Sep 2024

Combination therapy • Trial completion • Trial completion date • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

AMG 757 and AMG 404 in Subjects With Small Cell Lung Cancer (SCLC) (clinicaltrials.gov) - P1 | N=23 | Active, not recruiting | Sponsor: Amgen | Phase classification: P1b ➔ P1

Combination therapy • Phase classification • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

CodeBreak101: Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101) (clinicaltrials.gov) - P1 | N=1200 | Recruiting | Sponsor: Amgen | Trial primary completion date: Dec 2026 ➔ Sep 2025

Combination therapy • Metastases • Monotherapy • Trial primary completion date • Brain Cancer • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • KRAS

CodeBreak101: Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101) (clinicaltrials.gov) - P1 | N=1200 | Recruiting | Sponsor: Amgen | Phase classification: P1/2 ➔ P1

Combination therapy • Metastases • Monotherapy • Phase classification • Brain Cancer • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • KRAS

CodeBreak101: Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101) (clinicaltrials.gov) - P1/2 | N=1126 | Recruiting | Sponsor: Amgen | Trial primary completion date: Sep 2026 ➔ Dec 2026

Combination therapy • Metastases • Monotherapy • Trial primary completion date • Brain Cancer • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • KRAS

Blinatumomab in Combination With AMG 404 for the Treatment of Adults With Relapsed or Refractory B Cell Precursor ALL (clinicaltrials.gov) - P1 | N=17 | Completed | Sponsor: Amgen | Phase classification: P1b ➔ P1

Combination therapy • Phase classification • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology

CodeBreak101: Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101) (clinicaltrials.gov) - P1/2 | N=1143 | Recruiting | Sponsor: Amgen | Phase classification: P1b/2 ➔ P1/2

Phase classification • Brain Cancer • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Sarcoma • Solid Tumor • KRAS

CodeBreak101: Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101) (clinicaltrials.gov) - P1/2 | N=1143 | Recruiting | Sponsor: Amgen | Trial primary completion date: Jun 2026 ➔ Sep 2026

Trial primary completion date • Brain Cancer • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Sarcoma • Solid Tumor • KRAS

AMG 404 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=171 | Completed | Sponsor: Amgen | Active, not recruiting ➔ Completed

Metastases • Trial completion • Oncology • Solid Tumor

Safety and Efficacy of Therapies for Metastatic Castration-resistant Prostate Cancer (mCRPC) (clinicaltrials.gov) - P1/2 | N=65 | Terminated | Sponsor: Amgen | Active, not recruiting ➔ Terminated; Amgen made a business decision to discontinue all AMG 160 clinical trials. This decision is not related to safety.

Metastases • Trial termination • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

CodeBreak101: Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101) (clinicaltrials.gov) - P1b/2 | N=1143 | Recruiting | Sponsor: Amgen | Trial completion date: Jul 2027 ➔ Oct 2027

Combination therapy • Metastases • Monotherapy • Trial completion date • Brain Cancer • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Sarcoma • Solid Tumor • KRAS

AMG 757 and AMG 404 in Subjects With Small Cell Lung Cancer (SCLC) (clinicaltrials.gov) - P1b | N=23 | Active, not recruiting | Sponsor: Amgen | Trial completion date: Jan 2026 ➔ Jan 2025

Combination therapy • Trial completion date • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Study of AMG 994 Monotherapy and AMG 994 and AMG 404 Combination Therapy in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=11 | Completed | Sponsor: Amgen | Active, not recruiting ➔ Completed | Trial completion date: Sep 2023 ➔ Jun 2023

Combination therapy • Metastases • Monotherapy • Trial completion • Trial completion date • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Solid Tumor • MSLN

CodeBreak101: Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101) (clinicaltrials.gov) - P1b/2 | N=1143 | Recruiting | Sponsor: Amgen | Trial primary completion date: Jan 2025 ➔ May 2026

Trial primary completion date • Brain Cancer • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Sarcoma • Solid Tumor • KRAS

CodeBreak101: Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101) (clinicaltrials.gov) - P1b/2 | N=1143 | Recruiting | Sponsor: Amgen | Trial completion date: Jan 2029 ➔ Jul 2027 | Trial primary completion date: Jul 2026 ➔ Jan 2025

Combination therapy • Metastases • Monotherapy • Trial completion date • Trial primary completion date • Brain Cancer • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Sarcoma • Solid Tumor • KRAS

AMG 757 and AMG 404 in Subjects With Small Cell Lung Cancer (SCLC) (clinicaltrials.gov) - P1b | N=23 | Active, not recruiting | Sponsor: Amgen | Trial completion date: Aug 2025 ➔ Jan 2026

Trial completion date • Lung Cancer • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor

Study of AMG 994 Monotherapy and AMG 994 and AMG 404 Combination Therapy in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=11 | Active, not recruiting | Sponsor: Amgen | Trial completion date: Aug 2024 ➔ Sep 2023 | Trial primary completion date: Feb 2024 ➔ Jun 2023

Combination therapy • Metastases • Monotherapy • Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Solid Tumor • MSLN

Safety and Efficacy of Therapies for Metastatic Castration-resistant Prostate Cancer (mCRPC) (clinicaltrials.gov) - P1/2 | N=65 | Active, not recruiting | Sponsor: Amgen | N=136 ➔ 65

Enrollment change • Metastases • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

CodeBreak101: Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101) (clinicaltrials.gov) - P1b/2 | N=1143 | Recruiting | Sponsor: Amgen | Trial completion date: Apr 2028 ➔ Jan 2029 | Trial primary completion date: Feb 2026 ➔ Jul 2026

Combination therapy • Metastases • Monotherapy • Trial completion date • Trial primary completion date • Brain Cancer • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Sarcoma • Solid Tumor • KRAS